Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT05642832

Conditions

Respiratory Insufficiency

Diaphragm Injury

Lung Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Throughflow titration phase

Study Details

Brief summary:

Mechanical ventilation can lead to diaphragm and lung injury. During mechanical ventilation, the diaphragm could be completely rested or it could be overworked, either of which may cause diaphragm injury. Mechanical stress and strain applied by mechanical ventilation or by the patient's own respiratory muscles can also cause injury to the lungs. Diaphragm and lung injury are associated with increased morbidity and mortality. Throughflow is a novel system that can reduce dead space without the need to increase the tidal ventilation, reducing the ventilatory demands and respiratory drive.

Conditions

Respiratory Insufficiency

Diaphragm Injury

Lung Injury

Study ID

NCT05642832

Start date

Jan 1, 2024

Status verified date

Dec, 2024

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • PaO2/FiO2 less than or equal to 300 at time of screening
  • Oral endotracheal intubation with ETT 7.5 or 8.0 and on invasive mechanical ventilation
  • Bilateral airspace opacities on chest radiograph or chest CT scan

Exclusion Criteria:

  • Contraindication to esophageal catheterization (upper gastrointestinal tract surgery within preceding 6 weeks, bleeding esophageal/gastric varices)
  • Intubation for traumatic brain injury or stroke
  • Intracranial hypertension (suspected or diagnosed by medical team)
  • Anticipated liberation from mechanical ventilation within 24 hours

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Throughflow

Throughflow is a novel system that reduces anatomical dead space by providing a constant flow of fresh gas (i.e., gas that is free of CO2) during inspiration in patients receiving invasive mechanical ventilation. By clearing the CO2 that normally remains in the upper airway after exhalation (anatomical dead space), TF can dramatically reduce anatomical dead space without the need to increase the delivered VT, making it a safe strategy in terms of lung protection. This reduction in dead space reduces the ventilatory demands of the patients, reducing respiratory drive.

Interventions

Throughflow titration phase

Ventilation will be applied in the TF mode with TF set to 0 LPM for 10 minutes. Patients will receive assist through the NAVA line of the tri-piece (NAVA set to similar settings as Servo period, \~60-80 LPM flow). Ventilation with Throughflow will be started at a TF flow of 5 LPM, and the NAVA flow will be reduced by 5 LPM. After 10 minutes measurements will be collected. If Edi is greater than or equal to 4 µV, TF flow will be increased to 10 LPM and NAVA flow will be adjusted to keep total flow constant. Measurements will be collected again after 10 minutes. TF flow will be increased in steps of 5 LPM and measurements collected every 10 minutes until Edi is below 3 µV or TF flow reaches the total flow observed during the NAVA period.

After either the Edi target has been met or TF flow has reached the total flow, ventilation with TF will be reduced in steps of 5 LPM every 10 minutes (the reverse of the above), while NAVA flow is accordingly adjusted to keep total flow constant.

Primary outcome measure

  • Esophageal pressure swing (respiratory effort) [ Time Frame: 24 hours ]
  • Dynamic driving transpulmonary pressure (lung-distending pressure) [ Time Frame: 24 hours ]
  • Oxygenation (PaO2/FiO2 ratio) [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Rongyu ( Cindy) Jin

4163404800rongyu.jin@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Cindy Jin

rongyu.jin@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-12-11.